Vetmedin 0.75 mg/ml solution for injection for dogs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Pimobendan

Commercializzato da:

Boehringer Ingelheim Vetmedica GmbH

Codice ATC:

QC01CE90

INN (Nome Internazionale):

Pimobendan

Dosaggio:

0.75 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

pimobendan

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2014-08-22

Scheda tecnica

Health Products Regulatory Authority
06 August 2019
CRN008VPD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 0.75 mg/ml solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Pimobendan 0.75 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To initiate treatment of canine congestive heart failure originating
from valvular insufficiency (mitral and/or tricuspid
regurgitation) or dilated cardiomyopathy.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of hypertrophic cardiomyopathies or clinical
conditions where an augmentation of cardiac output is not
possible for functional or anatomical reasons (e.g. aortic stenosis).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of accidental subcutaneous injection temporary swelling and
mild to slight resorptive inflammatory reactions can occur
at or below the injection site.
For single administration only.
The product should be used for the initiation of treatment of
congestive heart failure in dogs, following a risk:benefit
assessment by the responsible veterinarian, taking into account the
overall health status of the dog. Before treatment,
diagnosis should be made by the means of a comprehensive physical and
cardiac examination which should include
echocardiography or radiography where appropriate.
Health Products Regulatory Authority
06 August 2019
CRN008VPD
Page 2 of 4
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the label to the physician.
Wash hands af